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Table 1 Patients demographic and baseline characteristics

From: Comparative evaluation of efficacy, pharmacodynamics, and safety of Hetero’s adalimumab (Mabura®, Hetero Biopharma Ltd.) and reference adalimumab (Humira®, Abbvie Inc.) in patients with active rheumatoid arthritis on concomitant methotrexate therapy

Characteristics

Test (n = 112)

Reference (n = 56)

p value

Gender

 Male

22 (19.6)

9 (16.1)

0.675*

 Female

90 (80.4)

47 (83.9)

Age (years)

43.90 ± 11.37

40.8 ± 9.99

0.088**

Height (cm)

158.27 ± 7.03

156.90 ± 7.22

0.240**

Weight (Kg)

58.58 ± 11.52

56.76 ± 9.47

0.310**

BMI (Kg/m2)

23.42 ± 4.88

23.08 ± 3.74

0.646**

Race

 Asian

112 (100)

56 (100)

0.557*

RA Score

8.96

9.08

NA

ACR Response Criteria

 Swollen Joint Count (SJC)

24.3 ± 13.24

23.8 ± 11.62

0.794

 Tender Joint Count (TJC)

29.1 ± 12.99

29.9 ± 11.95

0.695

 Patient’s Assessment of Pain

80.7 ± 8.77

80.6 ± 10.02

0.957

 Patient’s Global Assessment of Disease Activity

79.3 ± 9.90

76.8 ± 11.58

0.162

 Physician’s Global Assessment of Disease Activity

76.6 ± 8.85

76.6 ± 9.54

0.995

 Patient’s assessment of Physical Function

2.0 ± 0.40

1.9 ± 0.45

0.077

 Acute Phase Reactant (CRP (mg/dL))

24.8 ± 28.61

22.7 ± 22.64

0.632

DAS28-CRP

6.6 ± 0.84

6.5 ± 0.83

0.336

HAQ-DI

2.0 ± 0.40

1.9 ± 0.45

0.0775

IL-6 level

15.9 ± 15.78

18.0 ± 20.87

0.705

  1. Data are shown as mean ± SD or n (%); *p values are obtained by performing Fisher’s exact test; **p values are obtained by performing t-test; DAS28-CRP Disease activity score in 28 joints C-reactive protein; HAQ-DI Health assessment questionnaire disease index, CRP C-reactive protein; IL-6 Interleukin-6, TNF-alpha Tumor necrosis factor-alpha; NA: not applicable